63868-531 NDC - QC SPF 50 SUNSCREEN (AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%)

Drug Information

  • Product NDC: 63868-531
  • Proprietary Name: QC SPF 50 Sunscreen
  • Non Proprietary Name: Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%
  • Active Ingredient(s): 3 g/100g AVOBENZONE; 15 g/100g HOMOSALATE; 5 g/100g OCTISALATE; 10 g/100g OCTOCRYLENE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): LOTION

Labeler Information

Field Name Field Value
Labeler Name: CDMA
Product Type: HUMAN OTC DRUG
FDA Application Number: M020
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:12/22/2021

Package Information

No. Package Code Package Description Billing Unit
163868-531-08227 g in 1 BOTTLE, PLASTIC (63868-531-08)
263868-531-18227 g in 1 BOTTLE, PLASTIC (63868-531-18)

NDC Record

Field Name Field Value Definition
PRODUCT NDC63868-531This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
PRODUCT TYPE NAMEHUMAN OTC DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
PROPRIETARY NAMEQC SPF 50 SunscreenThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
NON PROPRIETARY NAMEAvobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
DOSAGE FORM NAMELOTIONThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
ROUTE NAMETOPICALA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
START MARKETING DATE12/22/2021The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGThe translation of the dosage form Code submitted by the firm.
APPLICATION NUMBERM020The translation of the route code submitted by the firm, indicating route of administration.
LABELER NAMECDMAThis is the date that the labeler indicates was the start of its marketing of the drug product.
SUBSTANCE NAMEAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH3; 15; 5; 10 
ACTIVE INGRED UNITg/100g; g/100g; g/100g; g/100g 

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This page was last updated on: 12/6/2025

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